Adverse Reaction Reporting Information

Who Can Report an Adverse Reaction?

Anyone -- including consumers, patients, caregivers, physicians, pharmacists, nurses, and dentists can report an adverse reaction to drugs or health products on the Canadian market.

Reporting is voluntary for the general population, but is mandatory for Market Authorization Holders (MAH) as required by Canada's Food and Drugs Act.

What to Report?

You do not have to be certain that a health product caused the reaction in order to report it. Adverse reaction reports are, for the most part, only suspected associations. Health Canada wants to know about all suspected adverse reactions, but especially if they are:

unexpected (not consistent with product information or labelling), regardless of their severity;

serious, whether expected or not; or

related to a health product that has been on the market less than 5 years.

When to Report an Adverse Reaction?

You should report an adverse reaction soon after the reaction occurred, even if you are not certain that a particular health product was the cause.

Why Report an Adverse Reaction?

All marketed drugs and health products have benefits and risks. Although health products are carefully tested before they are licensed in Canada, some adverse reactions may become evident only after a product is in use by the general population.

When you submit a suspected adverse reaction report, you contribute to the ongoing collection of information that occurs once health products are on the market.

Your report may contribute to:

the identification of previously unrecognized rare, or serious adverse reactions;

changes in product safety information, or other regulatory actions such as the withdrawal of a product from the Canadian market;

international data regarding benefits, risks or effectiveness of drugs and health products; and,

Please do not include sensitive personal information in the message box, such as your name, address, Social Insurance Number, personal finances, medical or work history or any other information by which you or anyone else can be identified by your comments or views.

Any personal information collected will be administered in accordance with the Department of Employment and Social Development Act, the Privacy Act and other applicable privacy laws governing the protection of personal information under the control of the Department of Employment and Social Development. Survey responses will not be attributed to individuals.

If you wish to obtain information related to this survey, you may submit a request to the Department of Employment and Social Development pursuant to the Access to Information Act. Instructions for making a request are provided in the publication InfoSource, copies of which are located in local Service Canada Centres.

You have the right to file a complaint with the Privacy Commissioner of Canada regarding the institution’s handling of your personal information at: How to file a complaint.

When making a request, please refer to the name of this survey: Report a Problem or Mistake on This Page.